CN103813745B - In order to visualize, be directed at and to melt transcutaneous device and the method for nerve - Google Patents

In order to visualize, be directed at and to melt transcutaneous device and the method for nerve Download PDF

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Publication number
CN103813745B
CN103813745B CN201280045755.2A CN201280045755A CN103813745B CN 103813745 B CN103813745 B CN 103813745B CN 201280045755 A CN201280045755 A CN 201280045755A CN 103813745 B CN103813745 B CN 103813745B
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China
Prior art keywords
signal
nervous tissue
ablation
equipment according
probe
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CN201280045755.2A
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Chinese (zh)
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CN103813745A (en
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T.朔伊尔曼
张达人
R.N.哈斯廷斯
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Boston Scientific Scimed Inc
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Boston Scientific Scimed Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0093—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy
    • A61B5/0095—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy by applying light and detecting acoustic waves, i.e. photoacoustic measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
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    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
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    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
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    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
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    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
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    • A61B2018/00482—Digestive system
    • A61B2018/00494—Stomach, intestines or bowel
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    • A61B2018/00505—Urinary tract
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    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
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    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
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    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
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    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/4461—Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
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    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A61N1/403—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals for thermotherapy, e.g. hyperthermia
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    • A61N2007/0021—Neural system treatment
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Abstract

Disclose a kind of equipment for identifying nervous tissue and the method for making and use described equipment.Example devices can include elongated shaft (124), and it has the distal region (120) being configured to percutaneous and being arranged in patient.Effective imaging arrangement (112,114) may be provided on distal region.Effective imaging arrangement is configured to from percutaneous position nervous tissue excitation signal and receives the remotely imaging of signal Lai Shi nervous tissue from percutaneous position.Effective imaging arrangement can include one or more probe (102).

Description

In order to visualize, be directed at and to melt transcutaneous device and the method for nerve
The cross reference of related application
The application enjoys the priority of the U.S. Provisional Patent Application sequence the 61/509th, 954 that on July 20th, 2011 submits to based on 35U.S.C. 119 request, and the full content of this application is herein incorporated by reference.
Technical field
The present invention relates to for visualizing, be directed at and melt the neural system and method including sympathetic activity division.Some embodiments of the present invention relate to be improved the system and method for kidney and/or cardiac function by neuromodulation.
Background technology
Neuromodulation therapy such as nerve ablation is useful for some situation.Such as, the renal sympathetic nerve discharge relevant with congestive heart failure can cause less desirable symptom, such as fluid retention.Interrupt this sympathetic activity and can alleviate these symptoms.A kind of technology for interrupting renal sympathetic nerve discharge is in that to melt the sympathetic nerve arranged partially around renal artery.Typical case's renal nerve ablation therapy relates to introducing in renal artery ablation catheter, and melts tremulous pulse in the various longitudinally and radially positions along tremulous pulse.This program completes when not identifying the ad-hoc location of nervous tissue or identifying nervous tissue.
Summary of the invention
It is capable of identify that nervous tissue can allow more targeted and therefore less wound therapy.Identify that the therapy of nervous tissue can be used for this type of kidney program and the program in health other places together with (that is, before, during and/or after) neuromodulatory techniques (as melting).
One embodiment belongs to a kind of equipment for percutaneous identification nervous tissue, and it includes the elongated shaft for percutaneous configuration, and is arranged on the effective imaging arrangement on the distal region of elongated shaft.Imaging arrangement is configured to from percutaneous position nervous tissue excitation signal and receives the remotely imaging of signal Lai Shi nervous tissue from percutaneous position.Imaging arrangement can include the first percutaneous electrode for excitation signal and for receiving the second percutaneous electrode of signal, maybe can include not only exciting and but also receive the single percutaneous electrode of signal.In another alternative, signal excitation can be provided by device outside, and probe can receive the signal excited by external probe.
Elongated shaft may additionally include the retaining element in distal region, and retaining element has contracted configurations and expanded configuration.The example of this type of retaining element includes inflatable air bag and self-expanding stent shape structure.One or more probes may be installed in the module at distal region place, and module can rotate relative to elongated shaft and/or longitudinally and/or move radially.Module can be located in retaining element, and in the case, module also can rotate relative to retaining element or longitudinally or move radially.Actuate device to be operably connected in module and provide this type of to move.
Probe can be acousto-optic sensor, and it includes radiofrequency launcher, e.g., and the phased array of luminous body and transducer.Luminous body may be configured to towards limiting position transmitting light, and change the position of intensity and the transmitting launched about probe.Luminous body can include element, and it can launch discrete light pulse, and can include the phased array that can launch the light-emitting component of coherent light.Signal processor is preferably operative connected on probe.Signal processor can be used for processing the signal coming from probe, and makes for making nervous tissue's imaging in combinations with probe, and could be configured with the signal coming from probe to measure temperature.
Elongated shaft may also include the neuromodulatory element in distal region, for instance, such as ablation.Ablation is preferably configured to Voice segment from neuromodulatory element a distance so that energy may pass through the first tissue to modulate nervous tissue.Neuromodulatory element can be ultrasonic ablation element, and may be configured to melt nervous tissue.
One embodiment belongs to a kind of Methods for Neuromodulation, and it step included has the nervous tissue to be modulated of the percutaneous location recognition from health and from percutaneous position change nervous tissue.Nervous tissue to be identified can open with the probe separation being identified, and can be opened by intervening tissue and probe separation.Identify during the modulation that the method may additionally include nervous tissue that the change of spirit tissue is such as the step of variations in temperature.
In some modification of the method, it is preferred to make nervous tissue's dyeing or the dyestuff that absorbed by nervous tissue in other cases introduce in relevant district.Therefore, the identification of nervous tissue can be assisted by this dyestuff, and the comparable nervous tissue of dyestuff self is bigger to excitation signal response.A kind of sensor envisioned to be used during identifying is acousto-optic sensor.
The modulation of nervous tissue can be completed by the probe spaced apart with nervous tissue.Energy can concentrate in nervous tissue through the first tissue to be directed at and to melt nervous tissue on non-demolition ground.Can be used for focusing on ultrasonic energy including the ultrasonic ablation body of the phased array of transducer to come for neuromodulation.
In the structure of embodiment described above, and extend from these embodiments, envisioned multiple alternative.The element of these alternatives is described below.
Such as, elongated shaft can be configured for the conduit of percutaneous configuration, contact pilotage or pin.Exciting probe can be individual component, and it is another transcutaneous component, or is being designed in vitro and in conjunction with receiving on the parts that probe uses in elongated shaft.Generally, this equipment may be configured to configure in order to percutaneous configuration, Ink vessel transfusing configuration or via natural or artificial any health opening or inner chamber.
Probe may be configured to preferably in excitation signal in nervous tissue, simultaneously substantially not excitation signal in the non-nervous tissue of other bodily tissue such as blood vessel wall.In order to preferably excite this type of signal, probe may be configured to launch light, coherent light or laser in the applicable part of spectrum as in the ultrared of spectrum, near infrared region, visible region or ultra-violet (UV) band, and therefore can excite fluorescence or other return signal from nervous tissue.
In some constructions, equipment can work together to the dyestuff being already applied in relevant district.Dyestuff can be the nervous tissue or molecule dyeing that are preferably and make the bigger concentration found in nervous tissue and the dyestuff being preferably the dyeing of Bu Shi non-nervous tissue, and probe can excite the fluorescence coming from this type of dyestuff.On the contrary, dyestuff can be the dyestuff being preferably and avoiding nervous tissue.When by fluoresce or other means come from this type of dyestuff shot images time, therefore probe can produce a kind of negative-appearing image of nervous tissue.
Probe may be configured to receive optical signal or acoustical signal.In some cases, excitation signal is optical signal, and such as laser, and to receive signal be optical signal.In some cases, excitation signal is optical signal, e.g., and laser or RF signal, and to receive signal be acoustical signal (such as, acousto-optic).In some cases, excitation signal is acoustical signal, and reception signal is acoustical signal (such as, ultrasound wave).
When probe structure becomes and generates acoustical signal, signal can be ultrasonic signal.Ultrasonic signal can have the frequency less than 100MHz or the frequency less than 90MHz or the frequency less than 80MHz, and also can have the frequency more than 20MHz or the frequency more than 40MHz or the frequency more than 60MHz, or has other frequency being suitable for.Probe can be additionally used in and generates the ultrasonic frequency being applicable to melt.
Equipment generally can include being connected to probe and being connected to the drive electronics of receptor probe.Can there is controller, controller is connected in drive electronics, and is configured to control the shake-up of probe.
In some cases, probe can include the phased array of emitter, and controller may be configured to the shake-up of each emitter in the phased array of controls emitter.The shake-up of the selectivity of the independent transmission body that controller is configured in phased array and timing electronically adjusts the focal depth of the phased array of emitter.The position of the focus of the phased array of emitter can adjust in a similar manner.Such as, control to may be configured to longitudinally move relative to conduit the focus of the phased array of emitter, and/or be configured to radially move relative to conduit the focus of the phased array of emitter.Additionally, the angular orientation of controller adjustable focus.
Receive the phased array receiving unit that probe can include being operably connected on controller.Receive the focal depth of the focus of the phased array of element, radially, longitudinally can be adjusted by controller with angular position.Emitter, reception element and/or unified probe member can for other elements of transducer or the detection technology being adapted in use to.
Equipment can include probe actuator, and it is used for making supravasal probe radially and/or longitudinally and/or rotatably move.Additionally, any phased array may comprise multiple element actuator of the element for being independently adjustable in phased array.
Equipment may also include setting element such as centring element, and the distal region of conduit is fixed on the center of blood vessel or against tube wall by it.Setting element can include air bag, non-blocking air bag such as leafy air bag, or includes the air bag of expandable screw element.Air bag can have transparent airbag wall, and can have transparent expansion fluid.Alternative setting element can be self-expanding setting element, e.g., is biased to multiple pillars or the bracket-like element of swelling state.
Probe can be located at any convenient position.Such as, probe can be positioned between the near-end of centring element and far-end, the distally of the far-end of centring element, or the nearside of the near-end of centring element.Probe and reception probe can be longitudinally overlapping along the longitudinal axis of conduit.
Some embodiments also include the ablation being arranged in distal region.Ablation is configured to produce energy by Voice segment in a distance, and energy passes the first bodily tissue and melts second bodily tissue at predetermined point place.Generally, Voice segment is at predetermined point place, and therefore excessively disperses in the region of the first bodily tissue, to modulate or otherwise to affect the first tissue.Ablation can use any applicable ablation techniques such as ultrasound wave, electromagnetic energy such as radio frequency, microwave energy, laser or low temperature energy.Generally, ultrasound wave and light are ablation energy focuses on certain distance through the technology used together with the system of intervening tissue with being best suitable for combining.Ablation can include energy cell array, and it is configured to cooperate to make for melting target tissue, e.g., and the phased array of transducer.Identical transducer is possibly used for probe function and ablation functionality.Phased array has focus, and focus can adjust as previously described.
One exemplary embodiment is pin or other transcutaneous device, and it has kidney modulation element and sensing element, such as ultrasonic element or acousto-optic element, or a part for acousto-optic element.When acousto-optic element, exciting element can, on probe, can be maybe independent component.Renal nerve modulation element can be ultrasonic element or other element being suitable for, those or medicine delivery element as described above.
Natural, any equipment mentioned above can be used in moving to the method for relevant district, excitation signal and reception signal use at the distal region percutaneous making equipment.In addition it is preferably a step to include processing and receives signal, and from the signal that device transmission receives, for instance, show on an electronic display by signal will be received.The mode of display signal includes showing receiving signal in the drawings or on the image in relevant district.The communication receiving signal may also include the audible instruction of offer.
Probe can when touching probe excitation signal rotatably and/or move longitudinally through relevant district.In certain embodiments, probe moves being moved in location and/or retaining element to expanding position, and probe moves about setting element.
The shake-up of probe generally includes the signal excited in nervous tissue.Such as, signal can fluoresce for nervous tissue or acoustical signal.In certain methods, it is preferred to the dyestuff being attached in nervous tissue is located in relevant district.Dyestuff can percutaneous, Ink vessel transfusing or per os provide, and can pass through independent injecting systems and provide.
The shake-up of probe can include generate light, as laser, ultraviolet light, infrared light or other be suitable for light or radio-frequency (RF) energy, or generate ultrasonic energy.Ultrasonic energy can with under the frequency less than about 100MHz or 80MHz provide, and/or with more than under the frequency of 20MHz, 40MHz or 60MHz provide.Touch probe to may also include such as by carrying out modulate emission energy towards focus emitted energy.People may select the focus in the pre-position from probe a distance, and emitted energy increases the energy of pre-position to greatest extent.People can modulate (such as by changing bifocal feature towards focus emitted energy simultaneously, change the radial distance of focus and probe, change the lengthwise position about probe, change the radial position about probe, change the intensity of the energy of focal point, widen focus, or the intensity changing the energy of focal point can include increasing or reducing by the energy of probe emission).
The step receiving signal can include receiving the step of sound wave.Controller can be used for processing selectively the signal of reception and determines and the feature of the tissue receiving the position that interelement separates.Such as, using the phased array receiving unit, people can concentrate on and receive the signal coming from the locality spaced apart away from phased array.This position can change as above, and can be Tong Bu with the focus of excitation signal.
When including those embodiments of ablation, method may also include the step triggering ablation.Ablation can have focus class above and excite element, and focus can change in a similar manner.People can follow the tracks of the change of the signal in certain time, and identifies the difference in signal.This effectiveness that can help to identify any position melted and ablation procedure.People can make regional imaging before ablation, and is continuing the imaging in region in some cases during ablation procedure, or makes regional imaging during or between ablation discontinuously.In certain methods, people can use ultrasonic signal to measure temperature.Therefore people can determine that treatment position, and then melt in treatment site, and then repeat this process by expectation.
These methods can use in any district of health, includes but not limited to, renal artery, coronary artery, vein, descending aorta, organ, stomach, colon, trachea or other relevant range.
Outlined above being not intended as of some exemplary embodiments describes each disclosed embodiment of the present invention or each embodiment.
Accompanying drawing explanation
Consider that the described in detail below of various embodiment is more fully understood from embodiments of the invention together with accompanying drawing, in the accompanying drawings:
Fig. 1 is Exemplary neural imaging and the diagram of modulation conduit；
Fig. 2 is the sectional drawing of the details of the far-end being shown in conduit；
Fig. 3 A illustrates the far-end of the exemplary catheter of original position；
Fig. 3 B illustrates the far-end of the exemplary catheter of Fig. 3 A of original position.
Although shown in the drawings already by way of example and will be described in its details, but the present invention is prone to carry out various remodeling and alterative version.It is to be understood, however, that be not intended as the aspect of the present invention is limited to described specific embodiment.On the contrary, it is intended to cover all remodeling, equivalent and the alternative that are within the spirit and scope of the invention.
Detailed description of the invention
For the term hereafter limited, these definition will be applied, unless different definition in the claims or provides in the other places of this description.
All numerical value are assumed in this article to be modified by term " about ", regardless of whether substantially point out.Term " about " is generally designated by the digital scope of the value (that is, having identical function or result) being equal to narration that those skilled in the art will think.In many cases, term " about " is represented by the numeral that includes being rounded to immediate significant figure.
The digital scope described by end points includes all numerals (such as, 1 to 5 include 1,1.5,2,2.75,3,3.80,4 and 5) within the scope of this.
Although disclose some magnitude range being suitable for and/or values of being suitable to various component, feature and/specification, but those skilled in the art passes through the guidance of present disclosure it will be appreciated that desired size, scope and/or value can deviate clear and definite those disclosed.
The singulative " one ", " one " and " being somebody's turn to do " that use in this specification and claims include plural reference, unless content clearly dictates otherwise.In this specification and claims use term " or " generally with it include " and/or " meaning use, unless content clearly dictates otherwise.
The element that term " preferably " and " preferably " are meant to modify affects unworthily about other element.Such as, exciting more than in other tissue of the signal that phrase " preferably exciting the signal in nervous tissue " is meant in nervous tissue.This is compared to only excitation signal in nervous tissue, and this is understood to be and means that other tissue can be excited equally, or non-preferentially excites the signal in nervous tissue, and this is understood to be and is meant to other tissue and is similarly excited.
Described in detail below should being read with reference to the drawings, element numbers similar in wherein different figure is identical.Detailed description and the accompanying drawing being not necessarily to scale depict one exemplary embodiment, and are not intended to restriction the scope of the present invention.The one exemplary embodiment drawn is only intended to as exemplary.The selected feature of any one exemplary embodiment may be incorporated in additional embodiment, unless the contrary clearly pointed out.
Fig. 1 is exemplary imaging and the diagram of neuromodulation conduit 100, and it can be used for identifying nervous tissue and neurad tissue conveying local treatment.As shown in a way of example, conduit 100 includes distally inflatable airbag part 102, and its therapentic part can being sent in patient comes imaging and conveying therapy to this therapentic part；Near-end 104, it is retained in outside patient during treating, and is easy to various equipment and is connected on conduit 100；And elongated member or catheter shaft 106, proximal device is connected in the inflatable airbag part of distally by it.
The elongated member 106 of conduit can include one or more inner chamber (not shown in figure 1).Inner chamber allows inflation fluid to be distad delivered to the interior room of air bag 102 from outside inflation fluid source 108.Elongated member 106 also includes conductor (not shown), it is from component such as sensing element (such as, sensing element 112a/112b, this can see in fig. 2) and air bag 102 in ablation (such as, ablation 114, this can see in fig. 2) transmit the signal of telecommunication signal processor 110 to the proximal end of conduit 100.
Signal processor 110 can process the signal of telecommunication and make to come from the signal characterization electrically of sensing element 112a/112b.Specifically, in some embodiments, signal processor 110 generates visual display, as, the isochronograph of tissue or equipotential diagram, internist can use visual display to identify the abnormal electrical pathway of the position in bodily tissue, and this can make the material standed for for neuromodulation or figure for identifying nervous tissue for internist.Visual display may be provided in user interface 116 (such as, flat faced display or other output device being suitable for).
Signal processor 110 can include circuit, it is used for receiving acoustical signal or optical signal or biopotential signals (such as, sense biopotential signals and they are amplified to differential amplifier or other amplifier of the level that can use in further processing), and process signal allows its analysis subsequently in one way, such as, carried by medical professional or consider that conveying therapy is to patient.
In some embodiments, signal processor 110 includes special circuit (such as, discrete logic components and one or more microprocessor；Special IC (ASIC)；Or specifically configured programmable device, for instance, e.g., programmable logic device (PLD) or field programmable gate array (FPGA)) for processing biopotential signals and showing the diagram performance of signal in the user interface.In some embodiments, signal processor 110 includes general purpose microprocessor and/or special microprocessor (such as, digital signal processor or DSP, it can be optimized to for processing image or biometric information), it performs the information that instruction receives, analyzes and shows and receives signal correction connection.In this embodiment, signal processor 110 can include programmed instruction, and it performs a part for signal processing when executed.Such as, programmed instruction can include by microprocessor or the firmware of microcontroller execution, microcode or application code.Above-mentioned embodiment is exemplary only, and readers will recognize that signal processor 110 can adopt any applicable form.
Controller 118 controllable sensing element 112a/112b and/or neuromodulatory element 114 in proximal end generate probe signals and/or treatment transmitting.In certain embodiments, independent controller can be used for controlling neuromodulatory element 114.Controller 118 self can adopt many multi-form.In some embodiments, controller 118 is the special circuit using various sensors, logic element and actuator.In other embodiments, controller 118 is computer based system, and it includes programmable element such as microcontroller or microprocessor, and it can perform the programmed instruction being stored in one or more memorizeies of correspondence.This type of computer based system can adopt many forms, including input with output device (such as, user interface and other common input and output device of being associated with computer system, as, keyboard, indicator device, touch screen, discrete switch and controller, printer, network connection, display lamp etc.), and can be combined with other systemic-function entirety, as, monitoring equipment, computer network, generally other device of use during program, etc..Such as, single computer based system can include processor, and it performs the image-forming information that instruction provides controller function, display and program (such as, coming from imaging device) to be associated；Display pressure, temperature and time information (such as, since the time in the past in the given stage starting treatment)；And it is used as the overall interface with conduit 100.Generally, various types of controllers are possible and can be devised, and can use any applicable controller 118.In addition, in some embodiments, controller 118 and signal processor 110 can be a part for single computer based system, and control to provide at least partially through performing in single computer based system programmed instruction with signal processing function.
Conduit 100 shown in Fig. 1 is the conduit of type on line.This type of conduit 100 uses the wire 120 of the remote extension from conduit 100.In some embodiments, wire 120 can be pre-positioned in patient body；Once wire 120 suitably positions, then air bag 102 (being in its deflated state) and elongated member 106 can be sent to therapentic part on wire 120.In some embodiments, the wire 120 of conduit 100 and cell parts 102 can in patient body together with move forward to therapentic part, wherein wire 120 (such as, some inches) at a certain distance guides air bag 102.When conductor part 120 reaches therapentic part, then air bag 102 can move forward on wire 120, until it also arrives at therapentic part.It is also contemplated that go out other embodiment, e.g., the steerable conduit of wire is not used.Additionally, some embodiments include introducing sheath, it can be similar to wire effect, and specifically, first it can be advanced to target site, and hereafter its other conduit portion can be advanced through immigration sheath.
Conduit 100 can include manipulator (not shown), and by manipulator, practitioner can guide wire 120 and/or air bag 102 and arrive therapentic part through patient body.In some embodiments, cryogen is discharged in cooling room air bag 102 can be made to be inflated to is similar to such shape shown in Fig. 1.In other embodiments, pressure source 108 can be discharged in the inner chamber of air bag 102 independent of cryogen and make air bag 102 inflate.Pressure source 108 can be additionally used in the anchoring members (not shown) on inflation wire 120 end.
Conduit 100 includes for being connected to the adapter on user interface 116, controller 118 and signal processor 110.User interface can include monitoring equipment, for instance, monitoring equipment can be used for temperature or the pressure of the far-end of monitoring tube 100.As described above, monitoring equipment can be incorporated integrally in individual system, and this system also provides for controller and signal processor.In order to contribute to being positioned in patient body by the air bag 102 of conduit 100, various indicia band (not shown) can also be provided at the proximally and distally place of conduit 100.When checking conduit by X ray or other imaging technique, indicia band can be radiopaque.Other change in conduit 100 be can be devised.Wire may differ from shown layout, and can be individually controlled from the cell parts of conduit.Additionally, in some embodiments, wire can not be used.
Fig. 2 illustrates some interior details of air bag 102.Air bag 102 includes airbag wall 122, and it can be formed by polymer, includes but not limited to polyolefin copolymer, polyester, polyethylene terephthalate, polyethylene, polyether block amide, polyamide, polyimides, nylon, latex or urethanes.Airbag wall 122 is preferably transparent, and is preferably also compliance.Air bag 102 includes inner module 124, and it can carry sensing element 112a/112b and neuromodulatory element 114.Inner module 124 can be cylindrical, and can be rotatably mounted relative to air bag.Electricity actuation mean 126 can allow inner module 124 to rotate relative to air bag.
Sensing element 112a/112b may be configured to identify nervous tissue, and can include acousto-optic element, ultrasonic element, optical sensor or other Nerve Testing element being suitable for.
Acousto-optic imaging uses the physical phenomenon of the sound wave produced by sample, and it uses electromagnetic energy to encourage.Generally, high intensity light pulses or radio-frequency (RF) energy is used to irradiate tissue.These pulses are preferably shorter (1ns-100ns).The Wavelength variable of light pulse, and in certain embodiments, in the scope of about 400nm to 500nm (such as, 450nm), or in some other embodiments, 1200nm can be may be about or bigger.These are only examples.Then, sound wave energy absorption from the tissue in irradiated volume in broadband generates.Short (such as, nanosecond) pulse can generate high-resolution acoustic return signals.Acoustic return signals can use supersonic detector to detect, and is subsequently processed the image providing spatial configuration to generate target tissue.The intensity of acoustic return signals is about the intensity of the pulse of relative photo and wavelength, and also about the local light absorptance of target tissue.Use acousto-optic imaging, it is possible to differentiate between histological types with high-resolution level (such as, the order of magnitude of about 20 microns to 200 microns).Using the preferred comparative dye with the high absorption coefficient of light, acousto-optic imaging technique can perform on cell and molecular level.
Sensing element 112a may be configured to launch coherent optical pulse (such as, there is the wavelength in the scope of about 400nm to 500nm, or there is the wavelength of about 1200nm or bigger), and sensing element 112b may be configured to receive the acoustical signal that generated by the pulse of the coherent light in nervous tissue.Such as, sensor element 112a can be laser diode, and sensor element 112b can be transducer.Sensor element 112a is preferably configured to coherent light is focused on focal point.Focus can be able to be maybe movable for focusing in advance.Such as, focus can be passed through the element actuator (not shown) under use each sensor element 112a, pass through sensor element 112a is used as phased array, by using one or more lens or other means being suitable for move.Sensor element 112b (reception element) can be configured to phased array, and it allows element or controller 118 or signal processor 110 to determine that reflected signal comes wherefrom.In this way, the graphics including the degree of depth through tube wall can produce, to identify the existence of nervous tissue.
In certain embodiments, sensor element 112b also can measure temperature and detection variations in temperature.The ultrasonic signal generated in the tissue is the function of the material character of tissue.Relevant nature is the velocity of sound through the material varied with temperature, and material is with the thermal expansion of temperature.These character vary with temperature and change, and affect the ultrasound wave generated by tissue in very predictable manner.Therefore, signal processor 110 may be configured to measure the variations in temperature in the temperature of tissue depth and/or detection tissue.This type of tissue measuring the neuromodulatory techniques that can be used for varying with temperature temperature and those positions to determine position experiences the time quantum of specified temp.
The dyestuff being preferably attached in nervous tissue or be attached in nervous tissue on the molecule of the higher concentration of discovery uses in combinations with sensing element 112.Dyestuff can have the high absorption coefficient of light under preset frequency, and sensing element 112a can launch the coherent light under this frequency.In this way, the sensitivity of pigment and corresponding nervous tissue can be strengthened by system, causes the more effective of nervous tissue or deeper of imaging.This type of dyestuff can be expelled in relevant range by independent pin before introducing the catheter in patient body, can introduce in body vessel by the inner chamber of conduit, maybe can pass through mode that another kind is suitable for as partly or orally introduce.
Other concentrating element U.S. Patent Application Serial the 61/324th owned together as being incorporated herein with its complete disclosure by reference, those described in No. 164 and/or U.S. Patent Application Pub.No the US2011/0257523rd, in combinations with arbitrary sensing element 112a, 112b uses, or uses in conjunction with ablation 114 as mentioned below.
Inner module 124 also includes ablation 114.As preferably, using and can melt and the ablation of intervening tissue of not breaking at certain depth.This type of ablation can include laser ablation element and ultrasonic ablation element.In certain embodiments, sensing element 112a or 112b can also function as ablation.But, it be also possible to use other ablation such as radio-frequency ablation element or cryogenic ablation element.In embodiment shown in fig. 2, ablation 114 be ultrasonic ablation element, and be the form of phased array, and this allows ablation to be directed at selected focal depth place to organize, and may also allow for focus and be moved laterally.
In use, conduit can percutaneously or be configured to relevant district at Ink vessel transfusing, and air bag 102 inflatable come during program by position for the far-end of conduit.Air bag preferably can use expansion fluid such as saline clearly to expand.Then, sensing element 112a/112b can be touched the image in the relevant district producing preferably to identify nervous tissue.Such as, in renal artery, nervous tissue is substantially located at the depth between 2mm to 8mm.Inner module 124 can rotate the image of the body vessel on all sides producing air bag to the nervous tissue in the district identifying contiguous air bag during imaging.Once recognize nervous tissue, rotatable ablation 114 aiming of inner module is located in nervous tissue.Then nervous tissue can be melted by shake-up ablation 114.Ablation 114 can focus on only ablation targets nervous tissue.
Fig. 3 A illustrates the distal part of the exemplary catheter 200 in body vessel inner chamber.Conduit 200 includes air bag 102 and module 124.Module 124 can use actuation mean 126 to rotate.Module 124 includes ultrasonic phased array 130 and light-emitting component 132.Light-emitting component 132 launches short optical pulse 134, and it is chosen to preferably excite nervous tissue 136.Therefore, any nervous tissue 136 launches sound wave 138, and it can be picked up by ultrasonic array 130.Module can rotate the nervous tissue identifying relevant range during this process.As shown in Figure 3 B, once have identified that nervous tissue, then ablation energy 140 can be focused to focus 142 to melt nervous tissue 136 by ultrasonic array.Module 124 is rotatable melts additional nervous tissue.The depth of field of focus can be depending on the degree of depth of nervous tissue and position changes.
Person of skill in the art will appreciate that the present invention can be presented as the various ways except described herein and the specific embodiment of conception.Therefore, the deviation in form and details can be produced when without departing from scope and spirit of the present invention described in such as claims.

Claims (12)

1., for identifying an equipment for nervous tissue, described equipment includes:
Elongated shaft, it has and is configured to the distal region that percutaneous is arranged in patient；
Being arranged on the effective imaging arrangement on described distal region, described effective imaging arrangement is configured by and excites the signal nervous tissue from percutaneous position and receive the remotely imaging of described signal Lai Shi nervous tissue from percutaneous position；And
Wherein said effective imaging arrangement includes one or more probe；Described elongated shaft includes the retaining element in described distal region, described retaining element has contracted configurations and expanded configuration, described elongated shaft also includes the module being arranged in described distal region, and wherein said one or more probe is arranged in described module, and wherein said module can rotate relative to described retaining element, described retaining element is expandable air bag, and described module is arranged on the intracavity of described air bag.
2. equipment according to claim 1, it is characterised in that described effective imaging arrangement includes for exciting the first percutaneous electrode of described signal and for receiving the second percutaneous electrode of described signal.
3. equipment according to claim 1, it is characterised in that described effective imaging arrangement includes the single percutaneous electrode for exciting and receive described signal.
4. the equipment according to any one of claim 1 to claim 3, it is characterised in that the one or more probe includes acousto-optic sensor, and described acousto-optic sensor includes: luminous body；Phased array with transducer.
5. equipment according to claim 4, it is characterised in that described luminous body includes laser diode.
6. equipment according to claim 4, it is characterised in that described Luminant structure becomes launches coherent light towards focus.
7. equipment according to claim 6, it is characterised in that described Luminant structure becomes to change the focal depth of described focus.
8. equipment according to claim 6, it is characterised in that described luminous body includes the phased array of light-emitting component.
9. the equipment according to any one of claims 1 to 3 and claim 5 to 8, it is characterised in that described equipment also includes the signal processor being configured with signal to measure temperature.
10. the equipment according to any one of claims 1 to 3 and claim 5-8, it is characterized in that, described equipment also includes ablation, and described ablation is configured to Voice segment in a distance from described ablation so that energy may pass through the first tissue to melt minor microstructure.
11. equipment according to claim 10, it is characterised in that described ablation is ultrasonic ablation element.
12. for the medical treatment device identifying and melting nervous tissue selectively, described device includes:
There is the catheter shaft of distal region；
It is attached to the air bag on described distal region；
Can be rotatably set in the module in described air bag, described module include for identify selectively nerve image-forming block and for melt nerve melt parts.
CN201280045755.2A 2011-07-20 2012-07-20 In order to visualize, be directed at and to melt transcutaneous device and the method for nerve Expired - Fee Related CN103813745B (en)

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